1.      Identify Total Design Control Requirement
Review of specific design control requirements, determine their source and identify implementation methods.

·         Design Control

·         US – Food Drug and Cosmetics Act & 21 CFR Part 820

·         EU – Medical Device Directive (MDD) & EN ISO 13485:2012

·         Canada – Canadian Medical Device Regulations (CMDR) & ISO 13485:2003

·         Conformity Assessment Paths

·         US – Premarket Submissions

·         EU – MDD Annex II Technical Files & Design Dossiers

·         Canada – Medical Device License

·         Identify Total Design Control Requirements

2.      Developing a Project Plan
Analysis of a small example project, identify stages and develop a Work Breakdown Structure (WBS) and a Gantt chart for the project.

·         Planning Stages

·         Interfaces

·         Project Management Techniques

·         Action List

·         Work Breakdown Structure (WBS)

·         Gantt Chart

·         Critical Path Method (CPM)

·         Program Evaluation and Review Technique (PERT)

·         Developing the Design History File (DHF)

3.      Developing and Resolving Input Requirements
Develop a set of design inputs for an example product and use the results to identify missing, incomplete or ambiguous requirements.

·         Requirements for the Procedure

·         Resolving design input issues (incomplete, ambiguous, or conflicting requirements)

·         Identifying the design input requirements

·         Performance

·         Functional

·         Safety

·         Regulatory

·         Market

·         Starting a trace matrix

·         Developing and Resolving Input Requirements

4.      Design Output Completeness
Review design outputs for an example product and identify essential requirements, acceptance criteria and gaps in the requirements.

·         Requirements for the Procedure

·         Total finished design output

·         The device

·         Packaging and labeling

·         Device Master Record (DMR)

·         Acceptance criteria

·         Essential product characteristics

·         Continuing the trace matrix

5.      Identifying and Resolving Problems
Design reviews systematically, and examine a design to evaluate its adequacy and capability with the intent to identify problems. Participants critique a design review to determine if it is sufficient.

·         Requirements for the Procedure

·         What needs to be covered

·         Who needs to attend

·         How to document results

·         Integrating risk management

·         Design Review at each Stage

·         Creating and Closing Action Items

·         Identifying and Resolving Problems

6.      Design Verification Methods
Examine paired design inputs and design outputs and determine the best tool for design verification. In some cases the analysis is extended to look specific aspects of the tools.

·         Requirements for the Procedure

·         Design Verification Tools

·         Failure Modes and Effects Analysis (FMEA)

·         Fault Tree Analysis (FTA)

·         Inspections and Tests

·         Document Review

·         Alternate Calculations

·         Similar Designs

·         The sample size question

·         Continuing the trace matrix

·         Exercise – Design Verification Methods

7.      Examining a Design Validation Plan
Critique a design validation that starts with user needs and intended uses. The plan uses production equivalents and simulated use conditions.

·         Requirements for the Procedure

·         Initial Products or Equivalents

·         Defined conditions or simulation

·         Software Validation

·         Risk Management (ISO 14971:2007)

·         Usability Engineering

·         Continuing the trace matrix

·         Examining a Design Validation Plan

8. Determining When a Process Must be Validated
Some production processes require process validation, while others do not. You’ll determine analyze processes transferred to production and document whether they require process validation.

·         Requirements for the Procedure

·         Process Controls, 820.70(a)

·         Purchasing Data, 820.50(b)

·         Process Validation, 820.75

·         Determining When a Process Must be Validated

9. Classify Changes as a Design Change or a Production Process Change.

QSIT informs the FDA Investigator that Production and Process Changes could be Design Changes. This exercise gives attendees an opportunity to classify changes and provides insight into the decisions to make in the QMS.

  • Requirements for the Procedure
  • Design change interrelationships — the five important considerations
  • When a production change is a design change
  • Does the design change create a new Device Identifier?
  • Does the design change require an updated 510(k)?
  • Does the design change impact the Risk Management File?
  • Is the design change an enhancement or a recall?
  • The design change flow chart shows the picture

Design change records

Classify changes as a design change or a production process change